Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04683484
Previous Study | Return to List | Next Study

A Clinical Trial to Assess the Safety and Immunogenicity of Nanocovax in Heathy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04683484
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nanogen Pharmaceutical Biotechnology Joint Stock Company

Brief Summary:
The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Nanocovax Biological: Placebo Phase 1 Phase 2

Detailed Description:

The clinical trial Phase 1, open-label, dose-escalation to evaluate the safety, tolerability, and initial assessment of immunogenicity of the vaccine Nanocovax intramuscularly in healthy Vietnamese adult volunteers.

The clinical trial Phase 2, randomization, double-blind, multicenter, placebo-controlled to evaluate the safety, immunogenicity, and determined the optimal dose of the Vaccine Nanocovax intramuscularly in healthy volunteers.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : August 10, 2021

Arm Intervention/treatment
Experimental: Low dose of Nanocovax
Intramuscular injection, two doses given 28 days apart
Biological: Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)

Experimental: Middle dose of Nanocovax
Intramuscular injection, two doses given 28 days apart
Biological: Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)

Experimental: High dose of Nanocovax
Intramuscular injection, two doses given 28 days apart
Biological: Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)

Placebo Comparator: Placebo
Intramuscular injection, two doses given 28 days apart
Biological: Placebo
0,5 mg Al PO4




Primary Outcome Measures :
  1. Solicited adverse events [ Time Frame: 7 days after each dose ]
    Percentage and severity level of participants reporting Solicited adverse events

  2. Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Geometric mean concentrations of Anti-S IgG at each time points


Secondary Outcome Measures :
  1. SARS-CoV-2 neutralizing titers [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Geometric mean titers of SARS-CoV-2 Neutralization antibody at each time points

  2. Participants achieving ≥4-fold rise of Anti-S IgG [ Time Frame: 0, 7, 28, 35, 56, 180 days after the first dose ]
    Proportion of participants achieving ≥4-fold rise of Anti-S IgG from before vaccination at each time points

  3. Cellular immune response (IFNγ) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of IFNγ from baseline after vaccination

  4. Cellular immune response (T CD4) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of T CD4 from baseline after vaccination

  5. Cellular immune response (T CD8) [ Time Frame: 28, 35, 56 days after the first dose ]
    Change of T CD8 from baseline after vaccination

  6. Serious adverse events [ Time Frame: 28 days after each dose ]
    Percentage of participants reporting Serious adverse events

  7. Unsolicited adverse events [ Time Frame: 28 days after each dose ]
    Percentage of participants reporting Unsolicited adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • From 18 to 50 years old in phase 1, from 12 to 75 years old in phase 2
  • Body Mass Index (BMI) between 18 and 28 kg/m2
  • The subject has good health, is assessed through medical history, clinical examination, and laboratory tests (such as hematology, biochemistry, urine ...) within the normal range evaluated by the clinician.
  • Subjects aged potentially pregnant should use effective contraceptive methods 4 weeks prior to screening and during the study and last until 6 months after the last injection.
  • Able and willing to participate in all activities in the clinical trial, including 6-month follow-up after vaccination.
  • Sign the consent form. For a subject from 12 to 17 years old, it is necessary to have a legal guardian sign the consent form to participate in the study

Exclusion Criteria:

  • Insufficient civil act capacity.
  • Subjects at high risk of SARS-CoV-2 infection.
  • Subject is/has ever had any acute or chronic medical condition, including but not limited to:

    • Have any inflammatory disease, respiratory tract infection, have any respiratory symptoms such as: cough, sore throat, difficulty breathing, wheezing due to respiratory symptoms within 07 days before screening. Fever (armpit temperature ≥ 37°C) for 3 days before vaccination.
    • History of any chronic respiratory illness such as bronchial asthma, chronic bronchitis, cystic fibrosis, chronic obstructive pulmonary disease (COPD).
    • Malignant disease
    • Immune disorders, using immunosuppressive therapy.
    • Cardiovascular diseases (including high blood pressure requiring drug treatment), liver disease, chronic kidney disease, endocrine diseases (including diabetes), hemoglobin disease ...
    • Neurological, psychiatric, epilepsy, or Guillian-Barré disorders.
    • Pathology of hemostasis.
    • Having any surgery for 8 weeks before screening.
    • History of organ transplantation.
  • Examination and testing results at the time of screening:

    • Systolic pressure above 140 mmHg and/or diastolic pressure over 90mmHg;
    • Systolic blood pressure less than 90 mmHg and/or diastolic pressure below 50 mmHg
    • Real-Time nasopharyngeal fluid test - PCR (positive) and/or anti S - IgG (positive) with SARS-CoV-2.
    • Women of potential pregnancy, a positive urine beta-hCG test at the time of screening.
    • Positive with HIV, hepatitis B (HBsAg), hepatitis C (ANTI-HCV) tests
    • WBC less than 3.5 x 10^9 cells / L
    • Lymphocytes of less than 1.0 x 10^9 cells / L.
    • Neutrophils less than 2.0 x 10^9 cells / L
    • Platelets below 140 x 10^9 cells / l
    • Hb less than 120 g/L for men and less than 100 g/L for women
    • ALT or AST is over 2 times the normal limit
    • eGFR of 90 mL/min/ 1.73m2 or less.
    • Abnormal ECG of clinical significance.
  • The Subject who have taken any drugs or treatments simultaneously and before:

    • Any drug or treatment that affects the immune system such as injectable anti-allergenic drugs, Globulin, Interferon, immunomodulators, cytotoxic drugs, or any other drug toxic to the body, for 90 days before screening.
    • Systemic steroids (oral or injectable; including intra-articular injection) regardless of dose except for topical form, for 28 days prior to screening.
    • Any vaccine within 28 days prior to screening or planned for in-study vaccination or after 6 months after the first vaccination.
    • Receive or donate blood/serum during the 8 weeks prior to the screening, or plan to receive or donate blood/serum during the study period.
  • The Subject that participated in any clinical trial 28 days prior to the screening date or intends to participate in another clinical study at any point in the study.
  • Women who are pregnant and breastfeeding or planning to become pregnant for the next 6 months from the time of the study 2 vaccines.
  • The Subject has a history of allergy to any of the vaccine components understudying or has a history of at least one past history of allergic or hypersensitivity reactions.
  • The Subject addicted to alcohol (drinking from 5 cups of alcohol daily, glasses of alcohol/can of beer), tobacco/water pipe addicts (smoking from 5 or more cigarettes), drug addiction, opioid dependence
  • The Subject is a member of the research team, sponsor employee, producer (Nanogen), and a person related by family (wife, husband, child, father, mother) with those subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683484


Contacts
Layout table for location contacts
Contact: Nhan Ho, PhD (+84) 28 7108 9688 clinicaltrial@nanogenpharma.com

Locations
Layout table for location information
Vietnam
Military Medical Academy Recruiting
Hanoi, Ha Dong, Vietnam
Contact: Men chu, MD    +84 388 959 096      
Sponsors and Collaborators
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Layout table for additonal information
Responsible Party: Nanogen Pharmaceutical Biotechnology Joint Stock Company
ClinicalTrials.gov Identifier: NCT04683484    
Other Study ID Numbers: NNG26
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No